Pain Relief Roll-on Gel
FDA Label NDC 72342-190

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J.r. Watkins, Llc. for the product Pain Relief Roll-on (NDC 72342-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Camphor 1.5%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain

Warnings

For external use only.

Flammable: Keep away from fire or flame and heated surfaces.

Do Not Use

  • On open wounds, damaged or irritated skin
  • With a heading pad or TENS device
  • With any other creams, ointments, sprays, liniments, or other topical products containing camphor

When Using This Product

  • Do not bandage tightly
  • Use only as directed
  • Avoid contact with eyes or mucous membranes

Stop Use And Ask A Doctor If

  • Condition worsens
  • Rash, itching, redness, or excessive irritation of skin develops
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

If Pregnant Or Breastfeeding

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older:
  • Apply to affected area not more 4 times a day
  • Massage painful area until absorbed into skin
  • Wash hands after each use with cold water
  • Children under 12 years of age: consult a doctor.

Other Information

  • Store away from children
  • Store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive Ingredients

Arnica montana flower extract, cholecalciferol, denatured alcohol, ethylhexylglycerin, glycerin, hydroxyethylcellulose, magnesium chloride hexahydrate, Mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 20, water

Questions Or Comments?

J.R. WATKINS, LLC
OAKLAND, CA 94612
1-888-384-1945
JRWATKINS.COM

Principal Display Panel - 85 G Bottle Label

ESTD 1868
J.R.
WATKINS
REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF
ROLL-ON

USED BY
ATHLETES

WITH NATURAL MAGNESIUM,
VITAMIN D, CAMPHOR
& PEPPERMINT

PENETRATING
PAIN RELIEF FOR
MUSCLE STRAINS
AND SORENESS,
AND ACHING JOINTS

Net wt. 3.0 oz (85 g)

Principal Display Panel (85 g Bottle Label)

Principal Display Panel (85 g Bottle Label)

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